Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG) (NCT02840409)

🧪 Interventions in This Study

• Vinblastine (DRUG)
• Bevacizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Children and adolescents aged 6 months to \< 18 years old with Low Grade Glioma (See Appendix I).
2. All patients must submit tumour tissue (fresh tumour tissue is recommended) and have pathological confirmation of LGG and determination of BRAF characteristics from the Hospital for Sick Children. Exceptions will be made for patients with neurofibromatosis type 1 who have not previously had a biopsy. NF1 patients are eligible without tissue confirmation but must have definitive clinical or radiographic evidence of tumour progression or risk for significant neurologic deterioration requiring immediate therapy. If a tissue sample for NF1 patients is available from a previous biopsy, it is required to be submitted for Central Review at the Hospital for Sick Children. Please refer to the lab manual for further details.
3. Patients must have progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (\< 95% or \> 1.0 cm2 residual tumour) with necessity to begin treatment because of a risk of neurological impairment with progression.
4. All patients on study must have measurable tumour (\>1.0 cm2 of residual tissue if resection has been performed) within 28 days of enrollment.
5. Patients must have received no prior therapy including chemotherapy, biological modifiers and/or radiation treatment for the tumour with the exception of surgery.
6. Patient is able to start treatment within 14 working days after randomization.
7. Post pubertal teenagers who are sexually active agree to use two methods of contraception during the treatment period and for at least 6 months after the last dose of study drug. Please refer to Appendix V for a list of acceptable methods of contraception.
8. Lansky performance status \> 50% for patients \< 16 years of age. Karnofsky performance status \> 50% for patients ≥ 16 years of age.
9. Patients with neurologic deficits must have deficits that are stable for a minimum of 1 week prior to enrollment.
10. Patients receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to enrollment.
11. Life expectancy \> 2 months at the time of enrollment.
12. Parents/guardians must provide written informed consent and to agree that they (and the patient) will comply with the study protocol.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (21 Sites)

• Children's Hospital Los Angeles — Los Angeles, California
• Children's Hospital Colorado — Aurora, Colorado
• Children's National Medical Center — Washington D.C., District of Columbia
• Children's Healthcare of Atlanta — Atlanta, Georgia
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• Children's Hospital at Westmead — Westmead, New South Wales
• Queensland Children's Hospital — South Brisbane, Queensland
• Women's and Children's Hospital — North Adelaide, South Australia
• Royal Children's Hospital — Parkville, Victoria
• Perth Children's Hospital — Nedlands, Western Australia
• Alberta Children's Hospital — Calgary, Alberta
• Stollery Children's Hospital — Edmonton, Alberta
• BC Children's Hospital — Vancouver, British Columbia
• Cancer Care Manitoba — Winnipeg, Manitoba
• McMaster Children's Hospital — Hamilton, Ontario
• Children's Hospital - London Health Sciences Centre — London, Ontario
• The Hospital for Sick Children — Toronto, Ontario
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec
• Montreal Children's Hospital — Montreal, Quebec
• CHU du Quebec-Universite Laval — Québec, Quebec
• Starship Children's Hospital — Grafton, Auckland

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Low Grade Glioma

• Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Patients Diagnosed With a Glioma — Detroit, Michigan
• Proton Radiation Therapy for Gliomas — Boston, Massachusetts
• Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial — Atlanta, Georgia
• MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas — Washington D.C., District of Columbia
• Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma — Los Angeles, California

Explore by condition: All Low Grade Glioma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.